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FDA 510(k)

AMADEUS ADAPTIVE COMPRESSION THERAPY

K-Number: K071763 · 2008-03-07

ApplicantConvatec
Decision Date2008-03-07
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMADEUS ADAPTIVE COMPRESSION THERAPY is the device name listed in this FDA 510(k) record. The listed applicant is Convatec. It received FDA 510(k) clearance on 2008-03-07 under 510(k) number K071763. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMADEUS ADAPTIVE COMPRESSION THERAPY?

AMADEUS ADAPTIVE COMPRESSION THERAPY is a medical device that received FDA 510(k) clearance on 2008-03-07. The listed applicant is Convatec. The 510(k) number is K071763.

When did AMADEUS ADAPTIVE COMPRESSION THERAPY receive FDA 510(k) clearance?

AMADEUS ADAPTIVE COMPRESSION THERAPY received FDA 510(k) clearance on 2008-03-07, under 510(k) number K071763.

Who is the listed applicant for AMADEUS ADAPTIVE COMPRESSION THERAPY?

The FDA 510(k) record lists Convatec as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMADEUS ADAPTIVE COMPRESSION THERAPY?

The FDA product code for AMADEUS ADAPTIVE COMPRESSION THERAPY is JOW.

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Other records listing Convatec as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).K250699Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K)K243228Flexi-Seal AIR (with ENFit Connector)K232665GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)K162906Flexi-Seal PROTECT Fecal Management SystemK083785VITALA CONTINENCE CONTROL DEVICE

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Related Devices (Code: JOW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261807Sequential Circulator (SC-4004-DL, SC-4008-DL)Bio Compression Systems, Inc.K254217AerloomEvolym, LLCK253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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